Duodenal mucosal resurfacing gains FDA breakthrough device designation for type 2 diabetes
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The FDA granted breakthrough device designation for a first-in-class duodenal mucosal resurfacing intervention for adults with insulin-treated type 2 diabetes, according to an industry press release.
The duodenal mucosal resurfacing intervention (Revita DMR, Fractyl Laboratories) is an outpatient endoscopic therapy that uses heat to resurface the lining of the upper intestine. Fractyl’s preliminary clinical findings suggest that treatment with Revita DMR may decrease insulin resistance, improve glucose response, lower body weight and reduce liver fat.
“We are thrilled to work closely with the FDA to accelerate the introduction of a potentially significant therapy for patients with type 2 diabetes who continue to struggle with the burden and risks of their disease,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl, said in the release. “Breakthrough designation provides recognition from the FDA of the potential value that Revita DMR can bring to patients and an opportunity for accelerated access for patients who need better treatment options.”
As Healio previously reported, data from the INSPIRE study presented at United European Gastroenterology (UEG) Week Virtual in October showed that more than half of patients who underwent duodenal mucosal resurfacing remained insulin free and saw improved metabolic parameters at 6 months and 1 year. The INSPIRE study presented was a single-arm, single-center, open-label study in which duodenal mucosal resurfacing was performed in 16 patients. All participants had type 2 diabetes treated with long-acting insulin, an HbA1c of 64 mmol/mol or less and C-peptides of 0.5 nmol/L or less. Despite eliminating insulin, researchers demonstrated that glycemic parameters for participants improved, with HbA1c falling from a mean of 7.4% to 6.6% at 6 and 12 months.
Data from a feasibility study published in Gastrointestinal Endoscopy in February and reported by Healio similarly showed that adding liraglutide (Victoza, Novo Nordisk) and lifestyle counseling to duodenal mucosal resurfacing eliminated the need for insulin therapy in most patients with type 2 diabetes through 18 months.
The FDA’s breakthrough devices program is designed to provide timely access to medical devices by speeding up their development, assessment and review while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorization. The Revita DMR currently has a European Union CE mark.
Fractyl is now enrolling patients in the REVITA-T2Di trial, which is designed to form the basis for a premarket submission to the FDA for adults with insulin-treated type 2 diabetes. The trial is a prospective, randomized, double-blind, sham-controlled study enrolling 300 participants at up to 35 sites globally.
Fractyl also announced that CMS approved coverage of routine costs for Medicare patients in the REVITA-T2Di trial. All eligible participants will receive study-related health assessments at no cost; this CMS decision allows reimbursement coverage to clinical research centers for certain trial-related expenses.
“We know that treatment alternatives to current drug therapy are desperately needed to address the type 2 diabetes epidemic,” Juan Carlos Lopez-Talavera, MD, PhD, chief medical officer of Fractyl, said in the release. “Providing a therapy that could improve glucose to target range while reducing the need for injectable insulin would be a quantum leap forward for patients. Fractyl is committed to advancing Revita DMR through the clinical and regulatory process to make a potentially meaningful difference in the lives of patients who are affected by this serious, chronic disease.”
To learn more about the REVITA-T2Di study and enrollment eligibility, visit www.revitastudy.com.
Perspective
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The observation that diabetes rapidly and considerably improves after gastrointestinal weight loss surgical procedures has triggered investigators to search for noninvasive approaches targeting the GI tract to improve type 2 diabetes, fatty liver disease and metabolic disease. Perhaps the main origin of these metabolic derangements is in the GI tract. Targeting the duodenum by duodenal mucosal resurfacing has been shown in several small trials with short follow-up times that it has favorable metabolic effects. While we need to wait to have better quality studies that are adequately powered to show safety, efficacy and durability of duodenal mucosal resurfacing, the recent recognition by FDA may pave the long road ahead.
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